DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan

Companion Spine

Status: Unknown

Conditions: Low Back Pain

Treatments: Other: Observational

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05201573

CP21001

Details and patient eligibility

About

A hybrid prospective/retrospective, multicenter, single-arm, data collection study.

Full description

Collect long-term follow-up data with x-rays and CT on subjects who received the DIAM™ Spinal Stabilization System through the original IDE protocol.

Data collected at one-time point from subjects with at least 5 years of follow-up data.

Enrollment: 175 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject randomized to the DIAM arm and treated with the DIAM™Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study.
• Willing and able to consent to study procedures

Exclusion criteria

• NA

Trial design

175 participants in 1 patient group

Subjects historically treated with DIAM

Description:

Subjects randomized to the DIAM arm and treated with the DIAM™ Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study

Treatment:

Other: Observational